At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Quality

Job Sub Function:

Quality Control

Job Category:

Professional

All Job Posting Locations:

Leiden, South Holland, Netherlands

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

As an Automation & Data Integrity Specialist in Netherlands, you will:

The employee is acquainted with the annual company and division goals and is aware of how he/she can influence these through his/her performance.

Individual contributor who is a developing subject matter expert, who works independently with minimal supervision. Directs groups in activities related to the organization's Data Integrity processes and procedures, from implementing quality standards through developing internal processes that optimize the Data Integrity function. Identifies compliance issues, supports in developing corrective action plans, and collaborates cross-functionally to implement new quality control procedures.

Coordinates inspections to ensure Data Integrity compliance with established companies and regulatory standards.

The responsibilities and the impact YOU will have: 

• Act as a Data Integrity (DI) specialist and monitors DI compliance during implementation of analytical equipment, applying ALCOA + guidance through all QC processes.
• Pertain advanced subject matter expertise on Data Integrity standards.
• Identifies DI issues, creates and owns Quality Risk Assessments, reviews result of quality audits and regulatory inspections and provides support in developing corrective action plans.
• Consults on newly developed testing procedures and other procedural changes.
• Coaches and trains colleagues in DI compliance
• NC/CPA DI Quality Lead/Owner
• Deploys and owns AT Site DI Gemba walks
• Leads Data Integrity governance process
• Provide DI Inspection readiness guidance. Support Internal/External Audits
• Provide DI assessment during equipment validations (e.g. audit trail validations etc)
• Provide DI guidance during Change control process
• Adhere to compliance best practices, EHSS regulations and lean principles.
• Perform other work-related activities assigned by supervisor.

We would love to hear from YOU, if you have the following essential requirements:

Bachelor’s degree (or equivalent) in a relevant discipline with 2-4 years of related working experience.

In addition:

• Didactical skills to effectively transfer information in a training environment.
• Experience in troubleshooting, advanced equipment/system knowledge.
• Acting as Subject Matter Expert during audits and inspections.
• Responsible for related deviation management and coordinator of appropriate corrective/preventive actions.

The anticipated base pay range for this position is 64,000.00 to 103,040.00 on an annual basis and includes 8% holiday allowance.

At Johnson & Johnson, we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear, fair, and respectful of your time.

Are you ready to make an impact?

If you want to leave your personal mark and be valued for who you are, Johnson & Johnson offers an unusual experience to professionals looking for an opportunity to work with hardworking people who share your real passion for caring in an environment that empowers you to drive your own career and that you feel you can bring your whole self to work.

We provide you an environment to fulfil your career aspirations as well as promoting your physical and mental wellbeing. You will receive a competitive compensation and benefits package as well as benefits that can be tailored to what is valuable to you throughout different stages of your life.

 

 

Required Skills:

 

 

Preferred Skills:

Coaching, Communication, Compliance Management, Controls Compliance, Econometric Models, ISO 9001, Performance Measurement, Problem Solving, Process Oriented, Quality Auditing, Quality Control (QC), Quality Standards, Researching, Standard Operating Procedure (SOP), Technologically Savvy